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Wire holder
EUDAMEDClass I (EU MDR)
Ref WHR-01Model for round wiresRef WHR-02Model for rectangular wires
Identity
- Device Name
- Wire holder EUDAMED
- Model / Reference
- for round wires EUDAMEDWHR-01 EUDAMEDfor rectangular wires EUDAMEDWHR-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-WHR-01GX EUDAMEDD-WHR-02GZ EUDAMED
- Basic UDI-DI
- B-WHR-01GX EUDAMEDB-WHR-02GZ EUDAMED
- EMDN Code
- L150799 ORTHODONTIC INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Wire holder by Astar Orthodontics Inc. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-WHR-01GX | Class I | Active |
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Manufacturer
- Manufacturer
- Astar Orthodontics Inc.
- EUDAMED SRN
- CN-MF-000028647
- Authorised Representative
- BIO CONCEPT, UNIPESSOAL, LDA PT-AR-000021480
Sources (2)
- EUDAMED 160902a9-2b32-4d63-954f-c858518d9d4e 61 fields · synced Jul 17, 2026
- EUDAMED a035b669-efe3-4040-b549-ab5c773e18ba 61 fields · synced May 16, 2026